Regulatory Affairs /Quality Assurance Managermyoscience

THIS JOB HAS EXPIRED

-- Provide leadership and expertise in maintenance of existing quality system (includes ISO 13485 Certification including CMDCAS, MDD compliance and 21 CFR 820 compliance).
-- Lead and direct continuous improvement programs, including scalability of existing systems for world-wide commercial business.
-- Host and lead all external audits with Notified Bodies, FDA, FDB. Respond to all corrective actions in a timely manner and drive all issues to closure.
-- Work with cross-functional teams in preparation of regulatory filings, including 510(k) notifications, IDE correspondence, Technical Dossiers, etc.
-- Interact with FDA/Notified Bodies/ Foreign Regulatory agencies to understand market requirements, resolve issues and satisfy all requirements.
-- Internally, partner with Operations group, providing quality oversight of pilot manufacturing line, tooling and calibration programs, material review board management and release of clinical and commercial product.
-- Partner with Contract Manufacturer in new product development and oversight of ongoing production to ensure delivery of quality products that delight our customers everytime.
-- Gather information, provide detailed reporting and provide management with key updates, including Management Review.
-- Interface with customers to ensure compliance with customer quality requirements. Communicate requirements internally as an integral part of product development team and working with Customer Experience group. Act as the primary resource in the investigation and response to customer complaints, rejections, and requests for corrective action to enhance a positive customer and supplier relationships in a cooperative environment, including continuous follow-up and interface with customers and/or suppliers on all quality issues.
-- Conduct internal and external audits to ensure compliance with all quality standards. Responsible for initiating corrective actions and driving root cause analysis and resolution of issues through team members and suppliers as necessary.
-- Responsible for CAPA program (including customer complaints), Audit program and Training compliance throughout the organization.
Budgetary responsibility for all quality functions.

You should have:
-- A minimum 5 years experience in medical device design and manufacturing environment.
-- A practical and working knowledge of ISO 13485, 21 CFR 820, CMDCAS, MDD.
-- A proven track record with regulatory filings and understanding market requirements.
-- BS Degree or higher in lifesciences or engineering.

You should be:
-- Detail oriented, well organized and have excellent communication skills.
-- Able to work well with cross-functional team and all levels of the organization.
-- Able to accomplish objectives with minimal supervision.